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RADIANT: A Study of Radium-223 Dichloride (Xofigo) vs Enzalutamide or Abiraterone (ARPIs, Androgen Receptor Pathway Inhibitors) in Patients with Prostate Cancer That Has Spread to the Bones (mCRPC, Metastatic Castration-Resistant Prostate Cancer)
EU CTIS ID: 2023-505830-89-00
What this study is testing
To assess the overall survival of radium-223 dichloride compared to second ARPI
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant must be ≥18 years of age inclusive, at the time of signing the informed consent. The lower limit may be higher if legally required in the participating country.
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
- Life expectancy ≥ 6 months.
- Able to swallow abiraterone and prednisone / prednisolone or enzalutamide as whole tablets/capsules.
- Laboratory requirements: a. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L b. Platelet count ≥ 100 x 10^9/L c. Hemoglobin (Hb) ≥ 9.0 g/dL (90 g/L; 5.6 mmol/L) d. Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN) (except for participants with documented Gilbert's disease) e. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN f. Creatinine ≤ 1.5 x ULN or estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m^2 as calculated using the Cockcroft-Gault equation g. International normalized ratio (INR) of prothrombin time (PT; PTINR) and partial thromboplastin time (PTT) ≤ 1.5 times the ULN. Participants treated with warfarin or heparin will be allowed to participate in the study if no underlying abnormality in coagulation parameters exists per prior history; weekly evaluation of PT-INR / PTT will be required until stability is achieved (as defined by local standard of care and based on pre-study PT-INR / PTT values) h. Serum albumin > 30 g/L I. Serum potassium ≥ 3.5 mmol/L.
- Male. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a. Male participants who have partners of childbearing potential (or whose partner is pregnant at study start) must use a condom during intercourse or sexual activity while receiving treatment and for 6 months following completion of treatment with radium-223 dichloride, 13 weeks after the last administration of abiraterone and 3 months after the last administration of enzalutamide. The contraception measures must be discussed with the participant. For a non-pregnant partner of childbearing potential, additional contraception recommendations should also be considered. Suitable contraception could be, for example, the use of an oral contraceptive by the partner. Note: Conservation of sperm: There are no human data on the effect of radium-223 dichloride on fertility; however, based on studies in animals, there is a potential risk that radiation from radium-223 dichloride could cause adverse effects on fertility. Participants should seek advice on conservation of sperm prior to treatment. b. Female participants: not applicable
You likely can't join if
- Active infection or other medical condition that would make prednisone / prednisolone (corticosteroid) use contraindicated.
- Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg). Participants with a history of hypertension are allowed provided blood pressure is controlled by antihypertensive treatment.
- Active or symptomatic viral hepatitis.
- History of pituitary or adrenal dysfunction.
- Any other serious illness or medical condition such as, but not limited to: a. Any infection ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 Grade 2. b. Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe orunstable angina, or New York Heart Association (NYHA) Class II to IV heart disease or cardiac ejection fraction measurement of <50% at baseline. c. Current clinical evidence of any uncontrolled cardiac arrhythmia. d. Crohn's disease or ulcerative colitis. e. Bone marrow dysplasia. f. Moderate and severe hepatic impairment (Child-Pugh Classes B and C). g. Unmanageable fecal incontinence.
- Any condition, which in the opinion of the investigator would preclude participation in this trial (eg, history of seizure).
See the full eligibility criteria
Who can join
- Participant must be ≥18 years of age inclusive, at the time of signing the informed consent. The lower limit may be higher if legally required in the participating country.
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
- Life expectancy ≥ 6 months.
- Able to swallow abiraterone and prednisone / prednisolone or enzalutamide as whole tablets/capsules.
- Laboratory requirements: a. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L b. Platelet count ≥ 100 x 10^9/L c. Hemoglobin (Hb) ≥ 9.0 g/dL (90 g/L; 5.6 mmol/L) d. Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN) (except for participants with documented Gilbert's disease) e. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN f. Creatinine ≤ 1.5 x ULN or estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m^2 as calculated using the Cockcroft-Gault equation g. International normalized ratio (INR) of prothrombin time (PT; PTINR) and partial thromboplastin time (PTT) ≤ 1.5 times the ULN. Participants treated with warfarin or heparin will be allowed to participate in the study if no underlying abnormality in coagulation parameters exists per prior history; weekly evaluation of PT-INR / PTT will be required until stability is achieved (as defined by local standard of care and based on pre-study PT-INR / PTT values) h. Serum albumin > 30 g/L I. Serum potassium ≥ 3.5 mmol/L.
- Male. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a. Male participants who have partners of childbearing potential (or whose partner is pregnant at study start) must use a condom during intercourse or sexual activity while receiving treatment and for 6 months following completion of treatment with radium-223 dichloride, 13 weeks after the last administration of abiraterone and 3 months after the last administration of enzalutamide. The contraception measures must be discussed with the participant. For a non-pregnant partner of childbearing potential, additional contraception recommendations should also be considered. Suitable contraception could be, for example, the use of an oral contraceptive by the partner. Note: Conservation of sperm: There are no human data on the effect of radium-223 dichloride on fertility; however, based on studies in animals, there is a potential risk that radiation from radium-223 dichloride could cause adverse effects on fertility. Participants should seek advice on conservation of sperm prior to treatment. b. Female participants: not applicable
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- Participants who have histologically confirmed adenocarcinoma of the prostate.
- Participants with mCRPC progressing on/after one line of an approved ARPI (eg. abiraterone, enzalutamide, apalutamide, or darolutamide, after being treated for at least 3 months) in an authorized prostate cancer indication.
- One prior taxane treatment regimen (at least 2 cycles) for metastatic prostate cancer (mHSPC and mCRPC) or refusal or ineligibility of such a regimen.
- Prostate cancer progression documented by PSA according to the Prostate Cancer Working Group 3 (PCWG3) criteria or radiological progression according to RECIST, version 1.1.
- At least 2 bone metastases on bone scan within 4 weeks prior to randomization with no current or history of lung, liver, other visceral, and / or brain metastasis.
- Symptomatic prostate cancer. A worst pain score (WPS) of at least 1 on the Brief Pain Inventory-Short Form (BPI-SF) Question #3 (worst pain in last 24 hours). This is to be assessed once during the Screening period.
- Maintenance of medical castration or surgical castration with testosterone less than 50 ng/dL (1.7 nmol/L). If the participant is being treated with luteinizing hormone-releasing hormone (LHRH) agonists or antagonists (participant who has not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to randomization and must be continued throughout the study. Skin cancer or low-grade superficial bladder cancer)
- Participants must be on a BHA treatment, such as bisphosphonates or denosumab treatment unless such treatment is contraindicated or not recommended per investigator's judgement and inclusion is agreed to by the medical monitor. Magnetic resonance imaging (MRI). Participants with history of spinal cord compression should have completely recovered.
What rules you out
- Active infection or other medical condition that would make prednisone / prednisolone (corticosteroid) use contraindicated.
- Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg). Participants with a history of hypertension are allowed provided blood pressure is controlled by antihypertensive treatment.
- Active or symptomatic viral hepatitis.
- History of pituitary or adrenal dysfunction.
- Any other serious illness or medical condition such as, but not limited to: a. Any infection ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 Grade 2. b. Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe orunstable angina, or New York Heart Association (NYHA) Class II to IV heart disease or cardiac ejection fraction measurement of <50% at baseline. c. Current clinical evidence of any uncontrolled cardiac arrhythmia. d. Crohn's disease or ulcerative colitis. e. Bone marrow dysplasia. f. Moderate and severe hepatic impairment (Child-Pugh Classes B and C). g. Unmanageable fecal incontinence.
- Any condition, which in the opinion of the investigator would preclude participation in this trial (eg, history of seizure).
- Hypersensitivity to the active substances or to any excipients of radium-223 dichloride, or abiraterone acetate or enzalutamide.
- Prior therapeutic systemic radiation with any radiopharmaceutical medication for the treatment of prostate cancer, including but o tlimited to lutetium-177, strontium-89, samarium-153, iodine-131, rhenium-186, rhenium-188, or radium-223. Radiopharmaceutical compounds used for diagnosis purposes only are allowed.
- Prior hemibody external radiotherapy is excluded. Participants who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for Hb, ANC, and platelet count.
- Blood transfusion or erythropoietin stimulating agents 4 weeks prior to Screening and during the whole Screening period before randomization.
- Excessive intake of biotin above the recommended daily dose of 30 μg. Biotin is found in multivitamins, including prenatal multivitamins, biotin supplements, and dietary supplements for hair, skin, and nail growth at levels that may interfere with laboratory tests.
- Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone / prednisolone equivalent daily for more than 2 months.
- Prior administration of an investigational therapeutic for CRPC.
- Previous (within the last 4 weeks of randomization) or concurrent participation in any interventional clinical study with investigationa lstudy drug administration.
- Pathological finding consistent with tumors with predominant neuroendocrine features or small cell carcinoma of the prostate (ie. tumors documented as having a small cell carcinoma histology and those having predominant neuroendocrine features [if mixed histology]).
- History of osteoporotic fracture.
- History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations.
- History of or known brain metastasis.
- Malignant lymphadenopathy exceeding 3 cm in short-axis diameter.
- Other malignancy treated within the last 3 years (except nonmelanoma skin cancer or low-grade superficial bladder cancer)
- Imminent spinal cord compression based on clinical findings and / or magnetic resonance imaging (MRI). Participants with history of spinal cord compression should have completely recovered.
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Canada
- Hong Kong
- Turkey
- United Kingdom
- Korea, Republic of
- Singapore
- Australia
- Russian Federation
- Brazil
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Canada; Hong Kong; Turkey; United Kingdom; Korea, Republic of and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.